Genta Incorporated (Nasdaq: GNTA) announced that the Company's proposal for a
randomized trial of Genasense(R) (oblimersen sodium) Injection in patients
with chronic lymphocytic leukemia (CLL) has completed Special Protocol
Assessment (SPA) by the Food and Drug Administration (FDA). The SPA, which
was submitted in December 2005, documents agreements regarding the trial's
design and planned analysis. Genta has filed a New Drug Application (NDA)
for Genasense plus chemotherapy, which is currently under review by FDA.
The NDA has a target action date for a marketing approval decision by
October 29, 2006 under the Prescription Drug User Fee Act (PDUFA).
The proposed trial, which will be conducted in symptomatic patients who
have not previously received chemotherapy, would randomize patients to
receive fludarabine plus rituximab (Rituxan(R); Genentech, Inc.) with or
without Genasense. The pivotal trial in the pending NDA employed a
combination of fludarabine plus cyclophosphamide with or without Genasense
in patients with relapsed or refractory CLL. The NDA was the subject of a
review by FDA's Oncology Drug Advisory Committee (ODAC) on September 6,
2006 and did not receive a majority vote to approve the application.
"We are pleased that FDA had no outstanding issues regarding the design
or analysis of this trial, and also with the Agency's agreement that there
were no safety issues that precluded the use of Genasense in previously
untreated patients," noted Dr. Raymond P. Warrell, Jr., Genta's Chief
Executive Officer. "While the NDA remains under active review, we will
provide Genasense at no cost to CLL patients in response to single-patient
IND requests (also known as "compassionate use" requests). We will not make
a decision whether to proceed with this new trial until we have had our
requested meeting with FDA to review the status of the pending NDA."
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified
product portfolio that is focused on delivering innovative products for the
treatment of patients with cancer. The Company's research platform is
anchored by two major programs that center on oligonucleotides (RNA- and
DNA- based medicines) and small molecules. Genasense(R) (oblimersen sodium)
Injection is the Company's lead compound from its oligonucleotide program.
The Company has submitted a New Drug Application (NDA) to the Food and Drug
Administration for the use of Genasense plus fludarabine and
cyclophosphamide for treatment of patients with relapsed or refractory
chronic lymphocytic leukemia (CLL). Genta has also completed a Marketing
Authorization Application to the European Medicines Agency (EMEA) for use
of Genasense plus dacarbazine for treatment of patients with advanced
melanoma. The leading drug in Genta's small molecule program is Ganite(R)
(gallium nitrate injection), which the Company is exclusively marketing in
the U.S. for treatment of symptomatic patients with cancer related
hypercalcemia that is resistant to hydration. For more information about
Genta, please visit our website at: genta.
Safe Harbor
This press release contains forward-looking statements with respect to
business conducted by Genta Incorporated. By their nature, forward-looking
statements and forecasts involve risks and uncertainties because they
relate to events and depend on circumstances that will occur in the future.
Forward- looking statements include, without limitation, statements about:
-- the Company's ability to obtain necessary regulatory approval for
Genasense(R) from the U.S. Food and Drug Administration ("FDA") or
European Medicines Agency ("EMEA");
-- the safety and efficacy of the Company's products or product
candidates;
-- the Company's assessment of its clinical trials;
-- the commencement and completion of clinical trials;
-- the Company's ability to develop, manufacture, license and sell its
products or product candidates;
-- the Company's ability to enter into and successfully execute license
and collaborative agreements, if any;
-- the adequacy of the Company's capital resources and cash flow
projections, and the Company's ability to obtain sufficient financing
to maintain the Company's planned operations;
-- the adequacy of the Company's patents and proprietary rights;
-- the impact of litigation that has been brought against the Company and
its officers and directors; and
-- the other risks described under Certain Risks and Uncertainties Related
to the Company's Business, as contained in the Company's Annual Report
on Form 10-K and Quarterly Report on Form 10-Q.
The Company does not undertake to update any forward-looking
statements. There are a number of factors that could cause actual results
and developments to differ materially. For a discussion of those risks and
uncertainties, please see the Company's Annual Report on Form 10-K for 2005
and its most recent quarterly report on Form 10-Q.
Genta Incorporated
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